The following description includes information that may be useful in understanding the present invention. It is not an admission that any such information is prior art, or relevant, to the presently claimed inventions, or that any publication specifically or implicitly referenced is prior art.
Except for vascular disease, cancer is the most frequent cause of death in industrialized countries. The traditionally accepted paradigm for treating cancers and tumors that comprise a single relatively well defined tissue mass has included the use of radiation and chemotherapy typically in association with surgical removal. In cases where surgical resection is an option, surgery is usually the most effective form of treatment. However, the effectiveness of surgical treatment depends on the complete removal of malignant tissue, encompassing the main tumor mass as well as branches and micrometastases which are frequently present in the vicinity of the main tumor.
When removing the main tumor, the surgeon also attempts to eliminate such local or regional micrometastases by resecting apparently normal tissue surroundings the tumor. That tissue is referred to as “margin tissue” or simply as “margin.” To what extent margin tissue is removed is subject to the surgeon's judgment. Typically, a margin of 0.5-2 cm around the entire tumor is acceptable. However, more extensive resections are not uncommon for invasive tumors. Even after careful resection of the tumor and margin, most types of tumors recur with a frequency of 10-40%. The recurrence rate depends on multiple factors including tumor size, type and location of the tumor, condition of the patient, etc. In order to reduce the rate of recurrence, surgery is usually followed by radiation and/or chemotherapy. Despite such secondary treatments recurrence rates are still uncomfortably high.
In addition to surgery and radiation, other methods of local tumor control are in use. These include Radiofrequency (RF) Ablation, Photodynamic Therapy (PDT), Cryotherapy (CRYO), Chemo-Radiation (CR), Brachytherapy (BT), Galvanotherapy (GT), and others. Surgery, RF, PDT, CRYO and CR rely on the complete removal or destruction of the tumor and margin tissues, whereas radiation, BT, and GT leave treated normal tissue more or less intact, although radiation and BT may cause severe scarring, fibrosis and vascular and neural damage. In any event, removal, scarring, and physical damage of healthy tissue can result in substantial disfigurement and substantial loss of physical use of body parts and/or functionality thereof. For example, most of the above listed current adjuvants to surgery for destroying or removing tumor masses cause nonspecific damage to normal tissues surrounding the tumor. Excision of a tumor mass can be completely debilitating to function where tumors must be removed from organs including the tongue, vocal chords, rectum, labia, penis, or to fine muscle and visual structures of the face tissue.
To avoid such disfigurement and preservation of function and to ensure that tissues surrounding the tumor are cleared of such cancerous cells, the present invention is provided as an adjuvant or neo-adjuvant to surgery as there is still a need in the oncology arts for a device and method of sparing apparently healthy tissues that lie adjacent to tumors and to reduce tumor mass, growth of the tumor, and recurrence rates.